Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Manager.
Expected placement at the Rome office with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience.
Hybrid work expected.
Retribuzione annua : 40000€ - 50000€
Esperienza:
da 6 a 10 anni
Basic qualifications :
* Master’s degree in Science, Engineering, Pharmaceutical Sciences or related technical discipline
* Min. 8 years of experience in GXP setting and/or Regulatory Affairs role
* At least 4 years of Product Quality Assurance experience in a GMP environment
* Advanced computer skills such as MS Office applications and good knowledge of enterprise systems like PDM, QTS Trackwise, Documentum platforms
* Good command of English; multilingual skills are a benefit
* Strong negotiation skills and diplomatic communication with internal and external customers
* Excellent verbal and written communication, including presentation skills
* Personal leadership to manage cross-functional projects
* Experience managing complex quality and compliance activities in manufacturing or with contractors
* Able to report remotely and work independently
Preferred Qualifications :
* Willing to lead by example, proactive, collaborative, and active listener
* Ability to manage stressful situations and focus on tasks under pressure
* Supervisory experience is desirable
* Up to 10% travel if required
* Broad GMP and technical expertise to handle emerging issues
* Conflict resolution skills
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Primary Responsibilities
* Initiate, review, and approve regulatory changes via Pfizer enterprise system (e.g., PDM) for changes initiated by or impacting ESOQ managed contractors.
* Support the closure of deficiency letters, CMC commitments, regulatory requests for renewals, new product registrations, and post-approval variations.
* Main contact for Global Chemistry, Manufacturing & Controls (GCMC) or Local Regulatory Affairs in Pfizer country offices regarding regulatory activities involving ESOQ contractors.
* Participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESOQ managed contractors and site quality visits if needed.
* Support and perform lot disposition for biotech semi-finished and finished products (if applicable).
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